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Perfusion Tubing Systems Packs (2017-10-10)
- Starting date:
- October 10, 2017
- Posting date:
- October 27, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64946
Affected products
- PERFUSION TUBING SYSTEMS PACK (AB1425)
- PERFUSION TUBING SYSTEMS PACK (086004)
Reason
LivaNova is recalling some Custom Perfusion Tubing Systems (PTS) packs containing Male Luer Connectors that may be partially occluded, following complaints of difficulties draining fluids on lines included in the PTS. The reported connector occlusion was generated during molding of one specific lot of Luer.
Affected products
-
PERFUSION TUBING SYSTEMS PACK (AB1425)
Lot or serial number
1706190110
Model or catalog number
AB1425
Companies
- Manufacturer
-
SORIN GROUP ITALIA S.R.L
VIA STATALE 12 NORD, 86, P.O. BOX 87,
MIRANDOLA, MODENA
41037
ITALY
B. PERFUSION TUBING SYSTEMS PACK (086004)
Lot or serial number
1706190111
Model or catalog number
86004
Companies
- Manufacturer
-
SORIN GROUP ITALIA S.R.L
VIA STATALE 12 NORD, 86, P.O. BOX 87,
MIRANDOLA, MODENA
41037
ITALY